Government Resolution No. 2525 dated the 29th of December, 2022, allows the use of components that are not listed in the technical documentation for the maintenance and repair of medical devices, provided that testing confirms the safety of their combined use. A similar decision will also be reflected in the form of amendments to Resolution No. 552 dated the 1st of April, 2022.
For such decision to be valid, technical, clinical and (if necessary) toxicological trials will be required to determine the safety of such components in the scope of the medical device. The All-Russian Scientific Research and Testing Institute of Medical Equipment (VNIIIMT) under the force of the Federal Service for Surveillance in Healthcare will act as the authorized body performing the trials.
The Federal Service for Surveillance in Healthcare also approves the list of documents required to be provided for the relevant tests. Upon completion of the preliminary accounting of components and parts that can be used as part of medical devices, but are not indicated in their documentation, the corresponding list with comments will be published on the VNIIIMT website for manufacturers to review.
This exemption will be valid for the devices with a risk of deficiency. Resolution No. 552 dated the 1st of April, 2022, signed by Mikhail Mishustin, as part of supporting the Russian market during the period of political and economic sanctions, already implies a reduction in the registration period for deficient medical devices, as well as a simplification of the registration procedure and updating the registration dossier.
The use of components that were not specified by the manufacturers will also help to speed up the maintenance and repair of medical devices for their successful application.